mdi Europa specializes on the services of an EU Auth. Rep. as laid down in the applicable EU medical devices Directives. However, our clients often require regulatory services over and above this.
We have thus built a network of regulatory affairs specialists and other specialized services to cover most of these needs. For example, our network offers:
- Market Entry and Market Development Services in Europe
- Technical File Compilation
- Compilation of quality management documentation
- Services with regards to WEEE and RoHS
- Translation Services
- Device approvals in the US/Canada
- Device Approvals in China
- Device Approvals in Latin America
- Device Approvals in the Middle East
This way, we intend to present our clients all necessary services, which we as their regulatory agency coordinate on their behalf.
Besides CE-marking, many additional services may be required – such as translations, market research, technical file compilations, etc. This page provides detailed information on the services available through our network. Learn more…
Although Europe is one of the biggest medical device markets world-wide, other international markets do not loose any of their importance. We have thus identified the best specialists world-wide to support you, our client, in the most ideal way. The following pages gives you an overview of services available outside the EU. Learn more…